Evaluation of Multimodal Preemptive Analgesia in Major Pediatric Abdominal Cancer Surgeries

National Cancer Institute, Egypt1 site in 1 country90 target enrollmentApril 1, 2015

Overview

Brief Summary

Surgical trauma initiates multiple physiological mechanisms that cause postoperative pain. Postoperative pain has nociceptive, inflammatory, and neuropathic components.Inadequate relief of postoperative pain leads to significant morbidity, delayed recovery, and mortality.Adverse reactions of medications used for postoperative pain management, particularly opioids, are common including pruritus and nausea and vomiting.Preemptive analgesia is defined as analgesic treatment that starts before surgical incision to prevent central sensitization caused by incisional and inflammatory injuries.Therefore, in this pilot study, the investigators are trying to evaluate safety and efficacy of preemptive multimodal analgesia compared with preemptive caudal analgesia and PCA morphine in pediatric cancer patient undergoing major abdominal surgery.

Detailed Description

Surgical trauma initiates multiple physiological mechanisms that cause postoperative pain. Postoperative pain has nociceptive, inflammatory, and neuropathic components.Inadequate relief of postoperative pain leads to significant morbidity, delayed recovery, and mortality.Despite the development of new drugs and analgesic techniques, up to 40% of hospitalized children - especially surgical patients - experiences moderate to severe pain. Adverse reactions of medications used for postoperative pain management, particularly opioids, are common including pruritus and nausea and vomiting.The incidence of opioid-related respiratory depression was reported to range from 0.11 to 0.41%.Regional anesthesia was suggested as an alternative to opioid-based analgesia in pediatric patients. Caudal epidural analgesia is a relatively safe and simple technique for postoperative pain management in children.However, there is a potential for adverse effects related to the technique of catheter placement or systemic toxicity of the local anesthetic. Preemptive analgesia is defined as analgesic treatment that starts before surgical incision to prevent central sensitization caused by incisional and inflammatory injuries.However, studies in animal models of incisional pain demonstrated that single analgesic treatment before the incision does not reduce postoperative pain. Once nociceptive afferent block subsides, the wound reinitiates central sensitization. Also, clinical trials reported similar results.Multimodal analgesia uses a combination of delivery routes administered at variable time points to optimize outcomes in the treatment of acute pain. Therefore, in this pilot study, the investigators are trying to evaluate safety and efficacy of preemptive multimodal analgesia compared with preemptive caudal analgesia and PCA morphine in pediatric cancer patient undergoing major abdominal surgery.

Registry

clinicaltrials.gov

Start Date

April 1, 2015

End Date

November 30, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

National Cancer Institute, Egypt

Responsible Party

Principal Investigator

Ehab Hanafy Shaker

Clinical professor of Anesthesia ,Critical care and Pain medicine

National Cancer Institute, Egypt

Eligibility Criteria

Inclusion Criteria

•were ASA I or II patients.
•Aged between 5 and 12 years.
•Both sexes.
•Scheduled for major abdominal surgery with a midline incision.

Exclusion Criteria

•included history of mental retardation or delayed development that may interfere with pain intensity assessment,
•Known or suspected allergy to any administered drugs.
•Active renal (creatinine clearance \<50).
•Hepatic (liver enzymes more than 10 folds).
•Respiratory (SPO2 \<92% on room air).
•Cardiac disease (ejection fraction \< 50%).

Arms & Interventions

Drug: Morphine

Morphine Group C (n=30) was the control group who received IV morphine in a dose of 0.1 mg/kg after induction of anesthesia

Intervention: Morphine

Procedure/surgery:Caudal levobupivacaine

In Caudal Group (n=30), patients were placed in the lateral position and received caudal epidural block after induction of anesthesia with levobupivacaine 0.125% , 1.1 ml/kg and morphine 0.02 mg/kg with maximum 20ml.

Intervention: Caudal levobupivacaine

Drug: Paracetamol and ketamine

The patients of Multimodal Group (n=30) received paracetamol infusion 10 mg/kg over 10 minutes and ketamine 0.5 mg/kg IV bolus followed by ketorolac 1 mg/kg infusion over 10 minutes.

Intervention: Paracetamol and ketamine